R350 IPN913606Recalls & reported problems
Teleflex Incorporated · R350 V2 Guidewire · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156101176), received between Dec 29, 2020 and Mar 5, 2021 — classified as 1 death, 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Use of Device Problem1
Patient problems
- Hematoma1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 5, 2021Use of Device Problem; Use of Device Problem
AS REPORTED: DURING A STUDY CASE, FOLLOWING RETROGRADE CTO PCI OF THE RCA, PATIENT DEVELOPED A SMALL INTRASEPTAL HEMATOMA WHICH WAS NOTED ON ANGIOGRAPHY BUT NOT VIA ECHOCARDIOGRAM. TREATED WITH TWO INTRACORONARY COILS WITH DECREASE FLOW NOTED. PATIENT WAS OBSERVED IN THE CATH LAB FOR AN ADDITIONAL 20 MIN. POST-COIL DEPLOYMENT WITH REPEAT ANGIOGRAPHY SHOWING NO FURTHER ENLARGEMENT OF THE HEMATOMA. SITE STATES THAT THE CAUSE OF THE HEMATOMA WAS DUE TO THE R350 EXTERNALIZATION GUIDEWIRE (STUDY DEVICE) BEING REMOVED FROM SEPTAL TOO QUICKLY.
Patient problems: Hematoma
MAUDE report 11424002 ↗DeathDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT EXPIRED POST INDEX PROCEDURE IN THE CTO PCI STUDY IN WHICH NUMEROUS DEVICES WERE USED. AT THE END OF THE INDEX PROCEDURE A PERFORATION WAS NOTED WHICH WAS TREATED WITH A COVERED STENT. ECHOCARDIOGRAM SHOWED STABLE PERICARDIAL EFFUSION W/O TAMPONADE. DURING EVENING POST-PROCEDURE SUBJECT WAS ON BEDSIDE COMMODE C/O NAUSEA WAS GIVEN A BASIN FOR EMESIS, HOWEVER HE COLLAPSED WAS BROUGHT BACK TO BED WHERE HE WAS FOUND PULSELESS. CPR AND ACLS PROTOCOLS WERE INITIATED. BEDSIDE CANNULATION OF VA ECMO CIRCUIT W/ PERFUSION AND TVP WAS PLACED. BEDSIDE TEE DEMONSTRATED STABLE PERICARDIAL EFFUSION W/O EVIDENCE OF TAMPONADE. SUBJECT WAS EMERGENTLY BROUGHT DOWN TO CATH LAB FOR CORONARY REPERFUSION. LMCA, LAD LCX OM1 AND OM2 THROMBOSED, S/P PTCA AND ASPIRATION THROMBECTOMY RESTORED TIMI3 FLOW TO LMCA, PROX LAD, LCX, OM1 AND OM2, NO FLOW TO DISTAL LAD DESPITE THROMBECTOMY, PTCA AND VASODILATOR PHARMACOTHERAPY. UPON RETURN FROM CATH LAB PATIENT CONTINUED TO DETERIORATE. SUBJECT SHOWED SIGNS OF HEPATIC AND RENAL FAILURE REQUIRING SLED. 4U PRBC FOR SIGNIFICANT ANEMIA WAS GIVEN (HGB 6.1 WITH MINIMAL IMPROVEMENT AFTER TRANSFUSION). VA ECMO RPM WAS INCREASED TO 4000 WITH IMPROVEMENT IN FLOWS (3.4-
Patient problems: Perforation
MAUDE report 11088581 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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